Public Health Service Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
June 14, 2016
Mr. Cesar J. Calvo, CEO/Owner
Pescatlantic Group, LLC
6100 Blue Lagoon Dr., Suite #325
Miami, FL 33126-2079
Dear Mr. Calvo:
We inspected your seafood importer establishment, located at 6100 Blue Lagoon Dr., Suite #325, Miami, FL 33126-2079 on May 10 and 11, 2016. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Because our inspection identified serious violations for 21 CFR Part 123, your fresh yellow fin tuna is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA’s home page at www.fda.gov.
To date, we did not receive a response to the FDA 483 issued to you on May 11, 2016. Your significant violations were as follows:
1. You must have and implement written verification procedures, to include product specifications and affirmative steps, for ensuring that the fish and fishery products you import into the United States were processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2). However, your firm has no written verification procedures or product specifications, and did not implement an affirmative step for fishery products imported from (b)(4) including but not limited to “fresh yellow fin tuna”. Your firm does not maintain a HACCP plan for (b)(4). on file, in order to meet the requirements of the affirmative step under 123.12(a)(2)(ii)(D), you must also have a written guarantee from your foreign processor that the imported fish or fishery product is processed in accordance with the requirements of the seafood HACCP regulation, 21 CFR Part 123. You are also required to have written verification procedures that include product specifications. You are reminded that the foreign manufacturer’s HACCP plan and the written letter of guarantee should be updated on an annual basis.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as HACCP and importer verification records, records that document performance and results of your affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on “detention without physical examination”. We may also seize your product(s) and/or enjoin your firm from further violating the Act.
This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B).
For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your response should be sent to Randall L. Morris, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions with regard to this letter, Mr. Morris can be reached at 407-475-4741 orRandall.Morris@fda.hhs.gov.